Sun Pharma Advanced Research Company (SPARC) and Sun Pharmaceutical Industries announced a worldwide licensing agreement on the development and commercialisation of SCD-044 which is being evaluated as a potential oral treatment for atopic dermatitis, psoriasis and other auto-immune disorders. SCD-044 is entering phase 2 clinical trials.
Under terms of the license agreement, Sun Pharma will pay SPARC an upfront payment of $20 million. SPARC will also be eligible to receive up to $125 million as milestone payments contingent upon the achievement of clinical, regulatory and sales milestones, as well as tiered royalties on sales.
Sun Pharma will be responsible for the development, regulatory filings, manufacturing and commercialisation of the product globally.
“SPARC is committed to progressing its pipeline to address the needs of patients. We are proud to be partnering with a global organisation with a footprint in auto-immune disorders” said Anil Raghavan, CEO, SPARC. This agreement with Sun Pharma follows the recent announcement that SPARC has acquired Bioprojet SCR’s share of rights to SCD-044.
“The in-licensing of SCD-044 adds to our speciality pipeline of innovative dermatology products. It also demonstrates our commitment to this important segment with significant unmet medical needs. SCD-044 may offer an alternate treatment option for patients in this segment who require systemic treatment and may offer benefits in terms of efficacy and safety over existing oral treatments for this population. SCD-044 has the potential to improve the current oral standard of care,” said Dilip Shanghvi, Managing Director, Sun Pharma.
SCD-044 is a novel orally bio-available Sphingosine-1-P (S1P1) receptor agonist for the treatment of inflammatory diseases such as atopic dermatitis and psoriasis. S1P1 receptor agonists are promising for the treatment of autoimmune inflammatory diseases as they cause diminished migration of lymphocytes out of lymphatic tissue. This results in a decrease in circulating lymphocytes, thereby reducing inflammation.
The phase 1 study of SCD-044 has been completed in healthy volunteers. This study established clinical proof-of-concept for SCD-044 in terms of its pharmacodynamics effects. Lymphocyte count reduction, a surrogate marker of efficacy for S1P1R agonists was observed at all dose levels evaluated